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A 7-year randomized, placebo-controlled trial assessing the long-term efficacy and safety of bazedoxifene in postmenopausal women with osteoporosis

effects on bone density and fracture

Palacios, Santiago MD, PhD1; Silverman, Stuart L. MD, FACP, FACR2; de Villiers, Tobie J. MBChB, MMed (O&G), FCOG, MRCOG3; Levine, Amy B. MD4; Goemaere, Stefan MD5; Brown, Jacques P. MD6; De Cicco Nardone, Fiorenzo MD7; Williams, Robert BSc4; Hines, Teresa L. BS4; Mirkin, Sebastian MD4; Chines, Arkadi A. PhD4 on behalf of the Bazedoxifene Study Group

doi: 10.1097/GME.0000000000000419
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Editorial
Editorial

Objective In a 3-year randomized, double-blind, osteoporosis treatment study (N = 7,492), bazedoxifene 20 mg and bazedoxifene 40 mg significantly (P < 0.05) reduced the risk of new vertebral fractures by 42% and 37%, respectively, compared with placebo in postmenopausal women with osteoporosis. This study evaluated the long-term (7-y) efficacy and safety of bazedoxifene in generally healthy postmenopausal women with osteoporosis.

Methods This was a second 2-year extension of the 3-year multicenter outpatient core study. During extension I (years 4-5), women receiving bazedoxifene 40 mg transitioned to bazedoxifene 20 mg. In extension II (years 6-7; N = 1,530), all bazedoxifene-treated women continued bazedoxifene 20 mg. Main outcome measures included year 7 endpoints: incidences of new vertebral and nonvertebral fractures, bone mineral density changes, and safety assessments.

Results At 7 years, the cumulative incidences of new vertebral fractures were significantly lower in the bazedoxifene (6.4%) and bazedoxifene 20 mg (7.6%) groups than in the placebo group (9.9%); the relative risk reductions were 36.5% and 30.4%, respectively (both P < 0.001). Bazedoxifene had no effect on the overall incidence of nonvertebral fractures (bazedoxifene, 11.2%; bazedoxifene 20 mg, 12.0%; placebo, 10.8%). The mean changes from baseline in lumbar spine bone mineral density were 2.95%, 2.73%, and 2.19%, respectively. Seven-year decreases in total hip bone mineral density were significantly smaller in the bazedoxifene (−1.15%) and bazedoxifene 20 mg (−1.19%) groups than in the placebo group (−2.53%; P ≤ 0.002). Bazedoxifene showed a favorable safety/tolerability profile across 7 years, with similar adverse events, serious adverse events, and study discontinuations in all groups.

Conclusions Efficacy and safety of bazedoxifene are sustained across 7 years in postmenopausal women with osteoporosis.

From the 1Palacios Institute of Women’s Health, Madrid, Spain; 2Cedars-Sinai Medical Center and University of California, Los Angeles, CA; 3MediClinic Panorama and Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa; 4Pfizer Inc, Collegeville, PA; 5University Hospital, Ghent, Belgium; 6CHU de Québec Research Center, Laval University, Quebec City, QC, Canada; and 7Università Cattolica del Sacro Cuore, Rome, Italy.

Received September 17, 2014; revised and accepted November 25, 2014.

Funding/support: This study was sponsored by Wyeth Research, which was acquired by Pfizer in October 2009. Medical writing support was provided by Joy Loh, PhD (MedErgy) and Linda Romagnano, PhD (Peloton Advantage) and funded by Pfizer. Statistical review of data was performed by Allan Pallay (Pfizer).

Financial disclosure/conflicts of interest: S.P. declares board membership at Servier, Pfizer, GlaxoSmithKline, Abbott, Ferrer, Bioiberica, Shionogi, Amgen, and Novo Nordisk; has served as consultant for Pfizer, Servier, Amgen, Merck Sharp & Dohme, Preglem, Leon Farma, Gynea, Sandoz, and Bayer; and has received payment for lectures from Servier, Pfizer, GlaxoSmithKline, Bioiberica, Shionogi, and Novo Nordisk. S.L.S. has received grants from the OMC Clinical Research Center; has received writing assistance, medicines, equipment, or administrative support from Stuart L. Silverman, MD—A Medical Corporation; has served as consultant for Stuart L. Silverman, MD—A Medical Corporation; has received payment for lectures from Stuart L. Silverman, MD—A Medical Corporation; and has received support for travel/meeting expenses from Stuart L. Silverman, MD—A Medical Corporation. T.J.d.V. declares board membership at Amgen and has received payment for lectures from Pfizer, Abbott, AbbVie, and Merck. A.B.L. was a former employee of Pfizer and owns stocks at Pfizer. S.G. declares board membership at Eli Lilly, UCB, and MSD; has served as consultant for Novartis; has received grants from Novartis, MSD, and Amgen; has received payment for lectures from Amgen; and has received support for travel/meeting expenses from MSD and Amgen. J.P.B. has received grants or has pending grants from Pfizer, Amgen, Eli Lilly, Merck, and Actavis; declares board membership at Amgen and Eli Lilly; has served as consultant for Amgen, Eli Lilly, Merck, and Radius; has received payment for lectures from Amgen, Eli Lilly, and Actavis; and has received payment for development of educational presentations from Eli Lilly. F.D.C.N. declares no conflicts of interest. R.W. is a current employee of Pfizer and owns stocks at Pfizer. T.L.H. was a former employee of Pfizer and is currently employed at Otsuka. S.M. was a former employee of Pfizer. A.A.C. was a former employee of Pfizer.

Address correspondence to: Santiago Palacios, MD, PhD, Instituto Palacios, Salud y Medicina de la Mujer, C/ Antonio Acuña 9, Madrid 28009, Spain. E-mail: spalacios@institutopalacios.com

© 2015 by The North American Menopause Society.